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High Versus Standard Volume Hemodiafiltration in Asia

NCT02092194 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-03-20

No results posted yet for this study

Summary

Online hemodiafiltration (HDF) may improve clinical outcome in end-stage renal disease. The supported mechanism is the improved clearance of uremic toxins by convective transporter. However, It has not been elucidated which convection volume is optimal, especially in Asia. A total of 60 participants receiving conventional hemodialysis will be randomly assigned to receive either high dose convective volume (33-43 L/treatment) post-dilution online HDF or standard dose (16.8-21.5 L/treatment) for 24 weeks. The primary outcome is the change of serum β2 microglobulin levels between baseline and after 24 weeks. The secondary outcomes will include changes in the nutritional markers, inflammatory markers, and blood pressure from baseline to after treatment.

This would be the first multicenter prospective, randomized controlled trial to determine whether large convective volume improves the treatment efficacy in Korean patients undergoing post-dilution online HDF.

Conditions

  • End-stage Renal Disease

Interventions

PROCEDURE

High Dose Online HDF

Convection volume; 33-43 L/treatment (140-180 mL/min)

PROCEDURE

Standard Dose Online HDF

convection volume; 16.8-21.5 L/treatment (70-90 mL/min)

Sponsors & Collaborators

  • Boryung Pharmaceutical Co., Ltd

    collaborator INDUSTRY

  • Korean Hemodialysis Study Group

    lead OTHER

Principal Investigators

  • Won-Yong Cho, MD · Korea University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-03-31
Completion
2016-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02092194 on ClinicalTrials.gov